The story behind our coformulation

The fixed-dose combination of ivermectin and albendazole is the result of more than 10 years of innovations carried out by African, Latin American and European organizations working in public-private partnership. Here are our main publications, projects and milestones. Explore the timeline of our work and discover how our team is advancing towards a better control of soil-transmitted helminths through innovation and collaboration.

FDC: Fixed-Dose Coformulation
IVM: Ivermectin
ALB: Albendazole

STOP2030

EDCTP3 funded project to take the fixed-dose coformulation of ivermectin and albendazole to the finish line.
Population Pharmacokinetics shows FDC doses are adequate

Using data from our previous clinical trials we evaluated the pharmacokinetic models and the exposure-response of our fixed-dose combination of albendazole and ivermectin in adults, adolescents and children, both healthy and infected with T. Trichiura. The results support the dosages (400mg/9mg and 400mg/18mg of albendazole and ivermectin) chosen for the two FDC variants.

Fix-dosing ivermectin regimens in MDA activities: a meta-analysis

We registered a new study to explore fixed-dose ivermectin regimens for mass drug administration (MDA) against STH and other NTDs. This research aims to compare weight-based, height-based, and age-based fixed-dose regimens in children aged 1 to 15, using data from global studies in regions affected by NTDs.

Registration of the REALISE Phase IV Clinical Trial

The REALISE study, an important goal of the STOP2030 project, has its protocol registered in clinicaltrials.gov and in the Pan African Clinical Trial Registry (PACTR). This clinical trial aims to determine the safety in large populations (~ 20,000 school-age children) of the fixed-dose combination, with a secondary goal of evaluating effectiveness in a mass drug administration context against STH by microscopy, against S. stercoralis by serology and to surveil anthelmintic resistance.

2024

Kick-off of the STOP2030 project

2023

STOP I & II

EDCTP2 funded projects aimed at evaluating the safety and efficacy of a fix-dose combination of albendazole and ivermectin
The ALIVE study: a pivotal, phase 2-3 clinical trial demonstrates safety and superior efficacy of the albendazole/ivermectin FDC

As one of the milestones of the STOP project, this phase II/III clinical trial was conducted in Kenya, Mozambique and Ethiopia between 2022 and 2023. Its results, published in The Lancet Infectious Diseases, show a safety profile equivalent to albendazole monotherapy and superior efficacy against T trichiura. They have been submitted to regulators, including EMA and Ghana’s FDA, with decisions anticipated in 2025.

A case for combining ivermectin and albendazole to control Strongyloidisasis

Following WHO’s inclusion of Strongyloidiasis in the targets of its 2021-30 Roadmap for soil-transmitted helminths, we outlined the challenges in developing a control program for Strongyloides stercoralis, including defining prevalence thresholds, improving diagnostics, and addressing the risk of ivermectin resistance, while highlighting the benefits of a fixed-dose combination of ivermectin with albendazole.

Fixed-dose ivermectin safety during the COVID-19 pandemic

The Ministry of Health of La Pampa, Argentina, ran a monitored emergency use of unregistered and experimental interventions (MEURI) program to assess the safety and posible clinical utility of high-dose ivermectin for COVID-19 patients. The program showed reduced ICU admissions and mortality in those treated with ivermectin compared to non-participants. The treatment was generally well-tolerated, with some reporting mild adverse events.

2022

Pilot trial to evaluate the safety of coadministering ivermectin and albendazole for T. trichiura

A pilot randomized clinical trial in a T. trichiura endemic area to determine the safety and efficacy of co-administration of albendazole monotherapy with high doses of ivermectin (> 400µg/kg). Results showed significantly improved egg reduction and cure rates compared to ALB alone, indicating that this combination is an effective option for controlling T. trichiura infections.

2021

Evaluating the safety of treating with high-dose ivermectin

We conducted a systematic review and meta-analysis on the safety of administering high-dose ivermectin (≥200 µg/kg, ≥400 μg/kg and up to 800 µg/kg). An analysis of six studies showed no significant differences in adverse events between standard and high doses, as most were mild or moderate.

Kick-off of the STOP projects

Early
Research

Studies on the presence of S. stercoralis, the challenges with diagnosis, and the need to incorporate ivermectin for a broader STH control

First trials of a fixed, high dose ivermectin tablet

In our phase I trial with 54 healthy adults, we tested two fixed doses of an 18 mg ivermectin tablet (18 mg and 36 mg) versus the standard weight-based regimen (150–200 μg/kg). Safety assessments showed no significant differences, with mild headaches reported as the most common adverse event. These results support the safety and effectiveness of fixed dosing for mass drug administration.

2018

Treating STH with ivermectin and albendazole in high prevalence communities in Argentina

In Tartagal, Argentina (2012-2015), the team assessed the impact of community-based albendazole and ivermectin preventive chemotherapy for soil-transmitted helminths (STH). Among 5,070 participants, STH prevalence dropped significantly after treatment, as did the anemia rates. The results point to community deworming with these medications effectively reducing STH prevalence and related morbidity.

2017

Identifying the burden of Strongyloides stercoralis

Our journey began when we conducted research on the presence of Strongyloides stercoralis infections, a parasite often overlooked in public health strategies for soil-transmitted helminths (STH). Our findings led us to emphasize the importance of incorporating ivermectin into the recommendations and plans of endemic countries as, unlike other STH, Strongyloidiasis can’t be managed with benzimidazoles. This further highlights the need for more studies on combining both drugs to control STH and St. stercoralis.

2013